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Medical Device - Regulatory Affairs Contractor

Medical Device - Regulatory Affairs Contractor

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Medical Device - Regulatory Affairs Contractor

  • Location:

    Zuchwil

  • Sector:

    Regulatory Affairs - Medical Device

  • Contact:

    yomi okuwobi

  • Salary:

    Negotiable

  • Job type:

    Interim/Contract

  • Contact email:

    yomi.okuwobi@msipharma.com

  • Job ref:

    009_1663316763

  • Published:

    16 days ago

  • Duration:

    14 Months

  • Startdate:

    03/10/2022

MSI Pharma is partnering with for one of the largest and diversified healthcare organizations in the world, on a MDR - RA role till 31/12/2023.

This is a collaborative role supporting the local regulatory team for various activities in conjunction with MDR compliance work. This role will involve supporting the RA Business Lead in the development and creation of IT System documentation for new functionality related to Technical Documentation requirements, business improvements and requirements to be established under MDR.

Job Description:

  • Perform User Acceptance Testing of newly implemented IT requirements as assigned
  • Create and support Software Life Cycle Development documentation
  • Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned

Required Skills and Experience

  • Experience in IT system documentation
  • Comprehensive knowledge in the handling with and of data in PLM and ERP system, preferentially experience in Agile e6, ERP (SAP), Windchill
  • Basic understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745, MDR)
  • Basic understanding of requirements of current Council Directive 93/42/EEC (MDD)

Start date: 03/10/2022

End date: 31/12/2023

Location: Luzernstrasse, Zuchwil, Switzerland

Full job specification(s) available upon request.

If you are interested, then please apply now! If you would like more information, then kindly drop me an email or give me a call.